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Completed

NCT Number: NCT07469813

Non-Surgical Periodontal Treatment With an Oscillating Ultrasonic Device With Adjunctive Root Polishing. A Randomized, Comparative, Prospective Clinical Trial.

Non-surgical periodontal treatment leads to periodontal inflammation resolution and amelioration of the clinical periodontal indices via the microbial load reduction. Additionally, non-surgical periodontal treatment can be performed with different instruments. Ultrasonic scalers with or without hand scalers are more frequently used during Phase I periodontal treatment, however the one who performs the treatment is committed to choose the tools that according to his judgment will lead to the best clinical outcomes following non-surgical periodontal therapy. The aim of this study was to evaluate the effectiveness of non-surgical periodontal treatment with a new oscillating ultrasonic device (Paro) with adjunctive root polishing versus traditional scaling and root planing with ultrasonic device and hand instruments, 3 and 6 months after treatment, at patients diagnosed with chronic periodontitis stage II, III and IV.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

251 Hellenic Airforce Hospital

Athens, 11525, Greece

About this study

Non-surgical periodontal treatment leads to periodontal inflammation resolution and amelioration of the clinical periodontal indices via the microbial load reduction. Additionally, non-surgical periodontal treatment can be performed with different instruments. Ultrasonic scalers with or without hand scalers are more frequently used during Phase I periodontal treatment, however the one who performs the treatment is committed to choose the tools that according to his judgment will lead to the best clinical outcomes following non-surgical periodontal therapy. The aim of this study was to evaluate the effectiveness of non-surgical periodontal treatment with a new oscillating ultrasonic device (Paro) with adjunctive root polishing versus traditional scaling and root planing with ultrasonic device and hand instruments, 3 and 6 months after treatment, at patients diagnosed with chronic periodontitis stage II, III and IV.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Systematically healthy adults
  • Signed informed consent
  • Periodontal disease diagnosis
  • Absence of periodontal treatment the previous 12 months

Exclusion criteria

  • Medical history that interferes with the healing process (CVD, organ transplantation, renal or hepatic failure etc)
  • Antibiotic and anti-inflammatory intake up to 1 month before treatment initiation
  • Pharmaceutically induced gingival enlargement
  • Pregnancy/ lactation

Treatment and study plan

Non-surgical periodontal treatment with U/S scalers and hand instruments

Procedure

Treatment of Group 1 was performed with U/S scalers (P3 & P1), hand instruments( Gracey curettes) and sub-gingival polishing.

Periodontal treatment with U/S scalers and Vector/Paro

Procedure

Treatment of Group 2 was performed with U/S scalers (P3 & P1), Vector-Paro System and sub- gingival polishing. In both groups, completion was decided upon the feeling of the operator that the root surfaces are smooth enough.

Primary outcomes

  1. Probing Pocket Depth

    Time frame: From enrollment to the end of post-treatment monitoring at 6 months

    Measurement from Free Gingival Margin to the base of the sulcus/pocket, in millimeters

Secondary outcomes

  1. Clinical Attachment Levels

    Time frame: From enrollment to the end of post-treatment monitoring at 6 months

    DIstance from cementoenamel junction to the base of sulcus/pocket, in millimeters

  2. Bleeding on probing

    Time frame: From enrollment to the end of post-treatment monitoring at 6 months

    Presence/Absence of bleeding on probing

  3. Root Dentin Hypersensitivity

    Time frame: From enrollment to the end of post-treatment monitoring at 6 months

    Feeling of sensitivity to cold stimuli measured with VAS scale

  4. Pain perception after treatment

    Time frame: From enrollment to the end of post-treatment monitoring at 6 months

    Feeling of pain after treatmetn measured in VAS scale

  5. Recession

    Time frame: From enrollment to the end of post-treatment monitoring at 6 months

    Distance from cemento-enamel junction to the free gingival margin in millimeters

Sponsors and collaborators

Lead sponsor

251 Hellenic Air Force & VA General Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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